FDA.reportPublic FDA data

Hydroxyzine Pamoate

Product NDC
0115-1803
Requested package NDC
0115-1803-02
11-digit product format
001151803
Labeler code
0115
Product ID
0115-1803_bfba144b-f9a0-46c4-b55c-fe452bcd9f57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA040156
Marketing category
ANDA
Marketing start
1996-07-15
Substance
HYDROXYZINE PAMOATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040156-001HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15
A040156-002HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A040156-001AB
A040156-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15a50c72e98297…
2026-08-01 22:54:322026-06A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040156-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A040156-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine PamoateHYDROXYZINE PAMOATEAmneal Pharmaceuticals of New York LLCbc82aaaf-30c7-4afe-a908-d138ea1268ef2026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156
ndc (package): 0115-1803-02
ndc (product): 0115-1803
ndc11 (package): 00115180302
Hydroxyzine PamoateHYDROXYZINE PAMOATEAvPAKbff08c15-89b1-00f7-e053-2995a90a2ad82026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156
HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEDirectRxd60603e7-15c5-7b01-e053-2995a90ad2522025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156
Hydroxyzine PamoateHYDROXYZINE PAMOATENuCare Pharmaceuticals,Inc.8a8416f8-18ce-99e6-e053-2995a90a10452024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156
Hydroxyzine PamoateHYDROXYZINE PAMOATEBryant Ranch Prepack4ea3336a-2cc8-4e43-bc55-455fca67976e2023-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156
Hydroxyzine PamoateHYDROXYZINE PAMOATEA-S Medication Solutions42186eab-89d1-4963-bfd8-087b3024af332023-11-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156
Hydroxyzine PamoateHYDROXYZINE PAMOATEBryant Ranch Prepackf24c19d4-fd3e-4ed3-aeb7-7bc5e0dd02442023-08-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156
Hydroxyzine PamoateHYDROXYZINE PAMOATEProficient Rx LP04657694-e8a8-4e52-a179-cfe7528197602022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156
Hydroxyzine PamoateHYDROXYZINE PAMOATEProficient Rx LP23561142-45e0-46f5-b17f-d67760b4db272022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156
Hydroxyzine PamoateHYDROXYZINE PAMOATENCS HealthCare of KY, LLC dba Vangard Labs207d3478-ac7f-485c-b8ca-e9fcebbdcd892022-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156
Hydroxyzine PamoateHYDROXYZINE PAMOATEAphena Pharma Solutions - Tennessee, LLCd6a1df2e-c111-4ee7-9d56-469db19b7c602021-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxyzine Pamoate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE PAMOATE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M20215MUFRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995253Internal RxNorm lookup
995278Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bc82aaaf-30c7-4afe-a908-d138ea1268efAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
aa1826f4-97c1-4705-bdf0-3bc7d234e618Product name220190618
75cb12ee-8eb2-4f1a-a332-5743a5d0da41Product name120151110
3ca5f78b-43dc-30fe-8014-55b922af52b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0115-1803-012024-01-31C16284748780-11030e365-6a41-111a-e063-dadaa90a10e2Hydroxyzine Pamoate Capsules, USP (25 mg and 50 mg) Rx only
0115-1803-012024-01-31C16284748780-11030e365-6a41-111a-e063-dadaa90a10e2Hydroxyzine Pamoate Capsules, USP (25 mg and 50 mg) Rx only
0115-1803-022024-01-31C16284748780-11030e365-6a41-111a-e063-dadaa90a10e2Hydroxyzine Pamoate Capsules, USP (25 mg and 50 mg) Rx only
0115-1803-022024-01-31C16284748780-11030e365-6a41-111a-e063-dadaa90a10e2Hydroxyzine Pamoate Capsules, USP (25 mg and 50 mg) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-1803-01Hydroxyzine Pamoate100 in 1 BOTTLE, PLASTICCAPSULE1009
0115-1803-02Hydroxyzine Pamoate500 in 1 BOTTLE, PLASTICCAPSULE5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1803-01EA - Each0115-1803730107f9-521b-4526-a235-af756d82018012018-05-09
0115-1803-02EA - Each0115-1803da4f5248-e4d1-4e39-931b-2ee090bd4aea12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1803HYDROXYZINE PAMOATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]9Current NDC, Legacy NDC, 2 package rows20240201_bc82aaaf-30c7-4afe-a908-d138ea1268ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN42186eab-89d1-4963-bfd8-087b3024af3313
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD42186eab-89d1-4963-bfd8-087b3024af3313
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNbc82aaaf-30c7-4afe-a908-d138ea1268ef9
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNbc82aaaf-30c7-4afe-a908-d138ea1268ef9
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDbc82aaaf-30c7-4afe-a908-d138ea1268ef9
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDbc82aaaf-30c7-4afe-a908-d138ea1268ef9
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYbc82aaaf-30c7-4afe-a908-d138ea1268ef9
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNf24c19d4-fd3e-4ed3-aeb7-7bc5e0dd02445
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNbff08c15-89b1-00f7-e053-2995a90a2ad85
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN23561142-45e0-46f5-b17f-d67760b4db275
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNbff08c15-89b1-00f7-e053-2995a90a2ad85
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDf24c19d4-fd3e-4ed3-aeb7-7bc5e0dd02445
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDbff08c15-89b1-00f7-e053-2995a90a2ad85
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD23561142-45e0-46f5-b17f-d67760b4db275
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDbff08c15-89b1-00f7-e053-2995a90a2ad85
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYbff08c15-89b1-00f7-e053-2995a90a2ad85
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN89175a33-d4a8-c1ef-e053-2a95a90a0fb14
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD89175a33-d4a8-c1ef-e053-2a95a90a0fb14
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN8a8416f8-18ce-99e6-e053-2995a90a10453
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNd0d91cc2-ef06-d019-e053-2a95a90aa3653
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD8a8416f8-18ce-99e6-e053-2995a90a10453
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDd0d91cc2-ef06-d019-e053-2a95a90aa3653
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNd6a1df2e-c111-4ee7-9d56-469db19b7c602
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDd6a1df2e-c111-4ee7-9d56-469db19b7c602
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN207d3478-ac7f-485c-b8ca-e9fcebbdcd891
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNa798f583-d690-728c-e053-2995a90af43a1
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN207d3478-ac7f-485c-b8ca-e9fcebbdcd891
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDa798f583-d690-728c-e053-2995a90af43a1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD207d3478-ac7f-485c-b8ca-e9fcebbdcd891
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD207d3478-ac7f-485c-b8ca-e9fcebbdcd891
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY207d3478-ac7f-485c-b8ca-e9fcebbdcd891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1803-0200115180302500 CAPSULE in 1 BOTTLE, PLASTIC (0115-1803-02) 500 capsule1996-07-150000-00-00NoNoCurrent